Pfizer and BioNTech's vaccine is 100 percent effective against COVID-19 in children ages 12 to 15, the companies said in a press release.
In a placebo-controlled Phase 3 trial of 2,260 participants ages 12 to 15 in the U.S., 18 adolescents who received placebo doses became infected, while none of the participants who received the real vaccine developed COVID-19.
The vaccine was "well-tolerated" by the children, and the side effects, commonly including pain at the injection site, fatigue, and fever, were similar to those seen among older teens and young adults.
The data is yet to be peer reviewed.
Vaccination of children
"We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15," said Pfizer CEO Albert Bourla. "We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year."
A safe return to the classroom is widely being discussed in many countries, and even though children are less likely to be affected by COVID-19, many experts say that ensuring vaccines are safe and effective in children is crucial to putting a stop to the pandemic.
Currently, Pfizer and BioNTech's vaccine is authorized to be distributed in the U.S. for use in people ages 16 and up. The safety demonstrated in this adolescent trial encouraged Pfizer and BioNTech to make the decision to begin testing its COVID-19 vaccine in even younger children, CNN reports. The companies launched a global vaccine trial that will ultimately recruit 4,500 children between the ages of 6 months and 11 years old.
"We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year," Bourla said.